U.S. Pat. No. 5,857,968 issued Jan. 12, 1999 entitled Coupling Device in Electroacupuncture and U.S. Pat. No. 5,961,453 entitled Tandem Irreversible Coupling Device in Electroacupuncture issued Oct. 5, 1999 to this applicant.
The first objective is to provide a coupling device in electroacupuncture to eliminate the transmission of infectious organisms such as bacteria, virus, fungus between patients and acupuncturists in electroacupuncture.
The second objective is to provide easy-to-use, single-use, disposable, recyclable consolidated electrical-lead acupuncture needle and, therefore, compel the disposable of all instruments after the application on a patient in acupuncture.
The third objective is to provide an easy-to-use, effective, reliable, fixed, i.e. immovable, consolidated electrical-lead acupuncture needle to ensure the ease and safety of application and to achieve the above objectives.
The fourth objective is to provide effective, optimal, and reliable electrical connection and contact between the electrical lead and the acupuncture needle and, therefore, ensuring the correct and optimal delivery of electrical current from the electrical lead to the acupuncture needle and pin in electroacupuncture.
"Acupuncture has been used by millions of American patients and performed by thousands of physicians, dentists, acupuncturists, and other practitioners for relief of prevention of pain and for a variety of health conditions." (National Institutes of Health Consensus Development Statement. Acupuncture. Nov. 3-5, 1997). The United States Food and Drug Administration has classified acupuncture pin as a medical device. The approval and consensus have resulted in tremendous growth of the application of acupuncture therapeutics by American acupuncturists.
LACK OF STERILE EQUIPMENT AND TECHNIQUE:
Transmission of infections and diseases in electroacupuncture between patients and acupuncturists is well documented in the scientific literature (Ernst E. et al. Life-threatening adverse reactions after acupuncture? A systematic review. Pain 71: 123-126, 1997). Two of the reasons are that there is a lack of sterile equipment and technique and the disregards for using sterile equipment and technique. The design deficiency of the prior art of acupuncture pin and equipment significantly contributed to aforementioned problems.
Presently, electroacupuncture using the micron-thick shaft of a metallic needle and pin being grasped by a relatively larger alligator clip of one end of an electrical lead are the most commonly tools used in America. Essentially, an acupuncture needle has a handle and a shaft with a bore and an acupuncture pin has a handle and a solid shaft. The electrical lead of prior art consisting of a plastic-insulated wire with one end connects to a grasping device such as an alligator clip and the opposite end connected to the electrical stimulator. To establish the flow of electrical current from the electrical lead to the shaft of the acupuncture needle, the alligator clip grasps onto the micron-thick shaft of the acupuncture needle for the purpose of transmitting electrical current from the stimulator via the wire, the grasping device, the acupuncture pin, into the patient.
First, the connection between alligator clip and the micron-thick shaft of the acupuncture needle and pin is loose and poor. The alligator clip is not designed for the purpose of grasping the micron-thin shaft of the acupuncture needle and pin whose diameter is too small to be effectively grasped by the alligator clip. As a result, unreliable delivery of correct ampere and voltage of the electrical current to the acupuncture needle and pin are common. Second, the contact parts of the alligator clip, after so many use, are often oxidized rendering the clip ineffective due to a barrier of a layer of nonconductive oxidized matters.
Breaching of the sterile technique is common. First, the alligator clip and the electrical lead, which are not sterile to start, will not fix to one position site of the shaft of the acupuncture needle and pin and will slide toward the acupuncture site of the skin during the application of the electrical lead leading to the contamination of the acupuncture skin site and, consequently, the transmission of infectious organisms via the acupuncture site of the skin. Second, the electrical lead and the alligator clip are reused from patient to patient. Eventhough the acupuncture needle and pin are sterile, the alligator clip and its electrical lead are not sterile.
The connection of acupuncture and alligator clip tend to swing loosely in the air without a means of attaching both instruments to the skin and, consequently, causing the weight of the electrical lead to easily dislodge the percutaneously implanted acupuncture needle and pin and exposing the sharp tip of the acupuncture needle and pin to inadvertently puncture the fingers of the acupuncturists resulting in the transmission of diseases in electroacupuncture.
The acupuncture needle and pin and, therefore, the sharp tip of the shaft are difficult to visualize especially in the clinical settings and, consequently, inadvertent puncture of the fingers of the acupuncturists is common leading to the transmission of diseases in electroacupuncture.
In brief, the design deficiency of the acupuncture needle and pin and the electrical lead of prior art promotes the transmission infection and diseases between patients and acupuncturists. The present invention solves the aforementioned problems.